Encapsulated valve system and method of use

ABSTRACT

An encapsulated valve system includes a first housing portion having a first facing surface, the first facing surface comprising a plurality of branch pathways formed as a recess within the first facing surface. The valve system further includes a second housing portion having a second facing surface, the second facing surface comprising a plurality of branch pathways formed as a recess within the second facing surface. A disposable conduit is configured to be interposed between the first and second housing portions and disposed within the recess of the first facing surface and the recess of the second facing surface. The disposable conduit is thus sandwiched between the first and second facing surfaces. A plurality of pinch valve actuators are mounted on one or both of the first housing portion and the second housing portion, the plurality of pinch valve actuators configured to pinch the disposable conduit at selective branch pathways.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/165,206, now issued as U.S. Pat. No. 9,447,888, which is acontinuation of U.S. patent application Ser. No. 13/554,983, filed onJul. 20, 2012, now issued as U.S. Pat. No. 8,656,951, which is also acontinuation of U.S. patent application Ser. No. 12/466,918, filed onMay 15, 2009, now issued as U.S. Pat. No. 8,235,067, the entiredisclosure of which is expressly incorporated by reference herein.

FIELD OF THE INVENTION

The field of the invention generally relates to fluid management devicesand, in particular, valve systems. More specifically, the inventionpertains to valve systems used by pharmaceutical and biologicalapplications or other hygienic process industries.

BACKGROUND OF THE INVENTION

Many commercial products are produced using chemical as well asbiological processes. Pharmaceuticals, for example, are produced incommercial quantities using scaled-up reactors and other equipment.So-called biologics are drugs or other compounds that are produced orisolated from living entities such as cells or tissue. Biologics can becomposed of proteins, nucleic acids, or complex combinations of thesesubstances. They may even include living entities such as cells. Inorder to produce biologics on a commercial scale, sophisticated andexpensive equipment is needed. In both pharmaceutical and biologics, forexample, various processes need to occur before the final product isobtained. For example, in the case of biologics, cells may be grown in agrowth chamber or the like and nutrients may need to be carefullymodulated into the growth chamber. Waste products produced by cells mayalso have to be removed on a controlled basis from the fermentationchamber. As another example, biologic products produced by living cellsor other organisms may need to be extracted and concentrated. Thisprocess may involve a variety of filtration and separation techniques.

Because there are a number of individual processes required to beproduce the final product, various reactants, solutions, and washes areoften pumped or otherwise transported to various subsystems usingconduits and associated valves. These systems may be quite cumbersomeand organizationally complex due to the large numbers of conduits,valves, sensors, and the like that may be needed in such systems. Notonly are these systems visually complex (e.g., resembling spaghetti)they also include many components that are required to sterilizedbetween uses to avoid cross-contamination issues. Indeed, the case ofdrug and biologic preparation, the Federal Food and Drug Administration(FDA) is becoming increasingly strict on sterilization procedures thatare required for drug and pharmaceutical preparations. This isparticularly of a concern because many of these products are produced inbatches which would require repeated sterilization of a variety ofcomponents.

Some attempts have been made at incorporating various disposableelements into the system. For example, conduits or lines connectingvarious systems or elements have been made of silicone. Unfortunately,silicone tubing or conduits often have to be reinforced along theirperiphery to avoid the possibility of leakage through an aneurysm or thelike that develops at the wall of the tubing. Reinforced silicone tubingis, however, rather expensive and is not as flexible as un-reinforcedsilicone. Systems that are disposable or incorporate disposable elementsare advantageous because they avoid the need for cleaning-in-place (CIP)cleaning, sanitization, or re-sterilization. Another problem withexisting fluid management and valving systems is that they contain asignificant residual volume. Namely, the volume contained within all theconduits and other constituents of the process may be quite large. It isdesirable to reduce the residual volume within the system in order todecrease the overall size of the system. Perhaps more importantly,however, there can be a significant dollar loss in residual product thatis contained within a system. For instance, some biologics need to beproduced in very small amounts—even for commercial applications. Thus,the actual cost of the drug per unit mass (or volume) is extremely high.Even a small amount of product that is lost in this residual volume maytranslate into a significant amount of money.

There thus is a need for an improved valve system that leverages thebenefits of disposable components. The valve system should reduce theorganizational complexity of existing systems. In addition, in mostapplications, it would be beneficial if the valve system could reducethe amount of residual volume within the system.

SUMMARY OF THE INVENTION

According to one aspect of the invention, an encapsulated valve systemincludes a first housing portion having a first facing surface, thefirst facing surface comprising a plurality of branch pathways formed asa recess within the first facing surface. The valve system furtherincludes a second housing portion having a second facing surface, thesecond facing surface comprising a plurality of branch pathways formedas a recess within the second facing surface. A disposable conduit isconfigured to be interposed between the first and second housingportions and disposed within the recess of the first facing surface andthe recess of the second facing surface. The disposable conduit is thussandwiched between the first and second facing surfaces. A plurality ofpinch valve actuators are mounted on one or both of the first housingportion and the second housing portion, the plurality of pinch valveactuators configured to pinch the disposable conduit at selective branchpathways.

In another aspect of the invention, an encapsulated valve systemincludes a first housing portion having a first facing surface, thefirst facing surface comprising a plurality of branch pathways formed asa recess within the first facing surface. The encapsulated valve systemincludes a second housing portion having a second facing surface, thesecond facing surface comprising a plurality of branch pathways formedas a recess within the second facing surface. A disposable conduit isconfigured to be interposed between the first and second housingportions and disposed within the recess of the first facing surface andthe recess of the second facing surface. A plurality of pinch valveactuators are mounted to the first housing portion and the secondhousing portion along a seam formed between the first facing surface andthe second facing surface, the plurality of pinch valve actuatorsconfigured to pinch the disposable conduit at selective branch pathways.

According to one aspect of the invention, the first and second housingportions may be formed from a metal such as, for instance, stainlesssteel. The first and second housing portions may be made of othermaterials, however. For instance, a polymer material such as a plasticmay be used encapsulate the disposable conduit.

The encapsulated valve system may include any number of branch pathways.For example, the valve system may include a single inlet that thenbranches into a plurality of outlets. Alternatively, there may be aplurality of inlets that branch into a plurality of outlets. In yetanother configuration, there may be a plurality of inlets and a singleoutlet. In one aspect, the plurality of branch pathways includes a firstpathway that extends across the first and second facing surfaces and asecond, separate pathway that extends across the first and second facingsurfaces. A third pathway bridges the first and second pathways. In thisconfiguration, the various pathways may have an H-shape.

According to another aspect of the invention, the flange fittings aredisposed at each location where the plurality of branch pathways exit orenter the first and second housing portions. The flange fittings maycomprise first and second halves that are located on respective firstand second housing portions. When the first and second housing portionsare placed in a facing arrangement, the complete flange fittings areformed. The flange fittings are configured so that other devices andcomponents may be secured to the fittings. For example, additionalconduits, valves, and the like may be coupled to the flange fittings.

In another aspect of the invention, the disposable conduit mayoptionally include seals or gaskets that are located at terminal ends.The seals or gaskets are dimensioned to fit within respective flangefittings located on the encapsulated valve system. The seals/gaskets maybe molded or otherwise integrally formed with the disposable conduit.These may be formed as the same material used in the underlyingdisposable conduit (e.g., silicone or plastic).

In another aspect of the invention, the plurality pinch valve actuatorsmay include manually-controlled actuators. In another aspect, however,the plurality of pinch valve actuators may includeautomatically-controlled actuators. These include, by way of example,pneumatic, electrical, solenoid-based, stepper-based, or servo-basedactuators. Of course, in a single encapsulated valve system, there maybe one or more manually-controlled actuators in combination with one ormore automatically-controlled actuators.

Fasteners may be used to secure the first housing portion to the secondhousing portion. The fasteners may be removed to permit the first andsecond housing portions to be opened up so that the internal disposableconduit may be disposed of. The fasteners may include screws, clamps,bolts or the like. It may even be possible to use an adhesive bondbetween the first and second housing portions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded, perspective view of an encapsulatedvalve system.

FIG. 2 illustrates another exploded, perspective view of an encapsulatedvalve system.

FIG. 3 illustrates a perspective view of the first housing portion ofthe encapsulated valve system along with a cross-sectional, perspectiveview of the disposable conduit.

FIG. 4 illustrates a side cross-sectional view of the second housingportion of the encapsulated valve system illustrating the pinch valveactuators.

FIG. 5 illustrates an exploded, perspective view of an encapsulatedvalve system according to another embodiment.

FIG. 6 illustrates a perspective view of the first housing portion ofthe encapsulated valve system of FIG. 5 along with a cross-sectional,perspective view of the disposable conduit.

FIG. 7 illustrates a perspective view of the second housing portion ofthe encapsulated valve system of FIG. 5 along with a cross-sectional,perspective view of the disposable conduit.

FIG. 8 illustrates an exploded, perspective view of an encapsulatedvalve system according to another embodiment.

FIG. 9 illustrates an exploded, perspective view of an encapsulatedvalve system according to another embodiment.

FIG. 10 illustrates a perspective view of the underside of a firsthousing portion of the encapsulated valve system of FIG. 9.

FIG. 11 illustrates a perspective view of the underside of a secondhousing portion of the encapsulated valve system of FIG. 9.

FIG. 12 illustrates an exploded, perspective view of an encapsulatedvalve system according to another embodiment.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIGS. 1-3 illustrate an encapsulated valve system 2 according to oneembodiment. The encapsulated valve system 2 includes a first housingportion 4, a second housing portion 6, and a disposable conduit 8 that,in an assembled state, is interposed between the first housing portion 4and the second housing portion 6. The encapsulated valve system 2further includes a plurality of pinch valve actuators 10, 12, 14, 16,18, 20, 22, 24. As seen in FIG. 1, pinch valve actuators 10, 12, 14, and16 are mounted on the first housing portion 4 while pinch valveactuators 18, 20, 22, and 24 are mounted on the second housing portion6. While eight (8) pinch valve actuators are illustrated in FIGS. 1-2(four (4) are illustrated in FIG. 3) more or less may be includeddepending on the particular configuration of the encapsulated valvesystem 2.

Still referring to FIGS. 1 and 2, the first housing portion 4 has afirst facing surface 30 that includes a plurality of branch passageways32 formed as a recess within the first facing surface 30 of the firsthousing portion 4. In particular, the recesses that form the pluralityof branch passageways 32 may be milled, worked, or molded into the firstfacing surface 30. The first housing portion 4 and the second housingportion 6 may be formed from a metallic material such as, for instance,stainless steel. Alternatively, the first housing portion 4 and thesecond housing portion 6 may be formed from a polymer material such asplastic or the like. In a similar manner, as best seen in FIG. 2, thesecond housing portion 6 has a second facing surface 36 and includes aplurality of branch passageways 38 formed as a recess within the secondfacing surface 36 of the second housing portion 6. The recesses formedin the second facing surface 36 may be formed is the same manner withrespect to those recesses within the first facing surface 30. Inparticular, the branch passageways 32, 38 are formed the first andsecond facing surfaces 30, 36, respectively, in a mirrored fashion suchthat the corresponding recesses match to form a substantially concentricpassageway (combined recesses 32, 28) when the first facing surface 30is brought into contact (or close proximity) with the second facingsurface 36.

Referring now to FIGS. 1-3, the plurality of branch passageways 32, 38terminate at respective flange fittings 40 a, 40 b, 42 a, 42 b, 44 a, 44b, 46 a, 46 b, 48 a, 48 b, 50 a, 50 b. Each flange fitting representsone-half of the complete flange fitting. Thus, when the first facingsurface 30 and second facing surface 36 are brought together or in closeproximity the complete flange fitting is formed. The complete flangefitting (e.g., 40 a and 40 b) appear circular in shape although othergeometries may be utilized. The flange fittings 40 a, 40 b, 42 a, 42 b,44 a, 44 b, 46 a, 46 b, 48 a, 48 b, 50 a, 50 b may be formed to conformto uniform standards within the relevant industry or application. Forexample, there are universal shapes and sizes that are typicallyemployed in various applications. While it is contemplated that theflange fittings 40 a, 40 b, 42 a, 42 b, 44 a, 44 b, 46 a, 46 b, 48 a, 48b, 50 a, 50 b may be designed to conform to these standards orcommercial conventions other sizes are also contemplated to fall withinthe scope of the invention. Each flange fitting 40 a, 40 b, 42 a, 42 b,44 a, 44 b, 46 a, 46 b, 48 a, 48 b, 50 a, 50 b optionally includes arecess 52 that is dimensioned to receive seal or gasket (explained morebelow). In this regard, a seal or gasket can be placed into the recess52 so that a good fluidic seal can be formed between other devices andapparatus and the various complete flange fittings.

As an alternative to the flange fittings 40 a, 40 b, 42 a, 42 b, 44 a,44 b, 46 a, 46 b, 48 a, 48 b, 50 a, 50 b described above, the branchpassageways 32, 38 may terminate in plain tube endings or other types ofconnectors known to those skilled in the art. The connectors may beintegrally formed into the first and second housing portions 4, 6 orthey may be secured after formation of the first and second housingportions 4, 6. For example, the endings or connectors may be welded,bonded, or otherwise affixed to the first and second housing portions 4,6. The endings or connectors may be configured to adapt to othermechanical or heat-weldable union types known to those skilled in theart. Optionally, the first and second housing portions 4, 6 may not haveany flange fittings, for example, as illustrated in FIG. 8.

Still referring to FIGS. 1-3, the first housing portion 4 and the secondhousing portion 6 may be secured to one another via a fastener 54. Inthe embodiment illustrated in FIGS. 1-3, the fastener 54 is a screw orbolt that passes through apertures 56 that are located in the firsthousing portion 4 and the second housing portion 6. The fastener 54 mayinclude other devices such as clamps, bolts or the like. It may even bepossible to use a water-soluble adhesive bond between the first housingportion 4 and the second housing portion 6. In one aspect of theinvention, the fasteners 54 are configured to be removable such that thefirst housing portion 4 can be separated from the second housing portion6 to remove the inner disposable conduit 8.

Referring now to FIG. 3, along pre-selected portions of the branchpassageways 32 there are provided apertures 60 that are dimensioned toreceive a pinching element 62 (seen in FIG. 4) from respective pinchvalve actuators 10, 12, 14, 16. Similar apertures 60 are located in thebranch passageways 38 of the second housing portion 6. Once suchaperture 60 is seen in FIG. 2. The locations of the various apertures 60are chosen to provide the ability to valve or gate a fluid medium intoone or more selected branch passageways 32, 38. In one aspect, thelocations of the apertures in the first housing portion 4 may bedifferent from those in the second housing portion 6. In this regard,the disposable conduit 8 is pinched only on one side within therespective passageway 32, 38. In this configuration, the variousactuators 10, 12, 14, 16, 18, 20, 22, and 24 operate in a so-calledblock and bleed arrangement. Certain actuators such as, for instance,pinch valve actuators 10, 12, 14, and 16 may act as blocking actuatorsthat block selected areas of the common line 8 a of the disposableconduit 8 as seen in FIG. 3. Still other actuators such as, forinstance, pinch valve actuators 18, 20, 22, 24 may act as bleedactuators that pinch branch lines 8 b as seen in FIG. 3. Alternatively,the apertures 60 in the first housing portion 4 are aligned with thelocation of the apertures in the second housing portion 6. In thisregard, the disposable conduit 8 may be pinched by respective pinchingelements 62 of opposing pinch valve actuators (e.g., pinch valveactuators 10 and 18).

FIG. 4 illustrates a cross-sectional view of the pinch valve actuators18, 20, 22, and 24 mounted on the second housing portion 6. Each pinchvalve actuator 18, 20, 22, 24 includes a pinching element 62 that, whenactuated, moves downward within the branch passageway 38 to pinch thedisposable conduit 8 (not shown in FIG. 4 for clarity). In theembodiment illustrated in FIGS. 1-4, the pinch valve actuators 10, 12,14, 16, 18, 20, 22, 24 are automatically-controlled actuators. Inparticular, the pinch valve actuators 10, 12, 14, 16, 18, 20, 22, 24 arepneumatically controlled pinch valve actuators. For example, compressedor pressurized (or even vacuum pressure) air is used to control theactuators in an on/off state. For example, the “off” state may includewhen the respective pinching element 62 is retracted while the “on”state may include when the respective pinching element 62 is extendedinto the branch passageway 32, 38. The pinch valve actuators 10, 12, 14,16, 18, 20, 22, 24 may each include an inlet 66 and an outlet 68(illustrated on pinch valve actuator 10). The pinch valve actuators 10,12, 14, 16, 18, 20, 22, 24 may include air-to-spring or air-to-airactuators.

While pneumatically-operated pinch valve actuators 10, 12, 14, 16, 18,20, 22, 24 are illustrated in FIGS. 1-4, the pinch valve actuators maybe electrical in nature. These include, by way of example, various typesof actuators including solenoid coil-based actuators, steppermotor-based actuators, or servo-motor-based actuators. In yet anotheralternative, the pinch valve actuators 10, 12, 14, 16, 18, 20, 22, 24may even be manually-controlled though the use of a knob, lever, or thelike. In addition, some pinch valve actuators may be automaticallycontrolled while others may be manually controlled.

Turning now to FIGS. 1-3, the disposable conduit 8 may include a seal orgasket 70 located at terminal ends thereof. Six (6) such seals 70 areillustrated in FIGS. 1-3. The seals 70 are dimensioned to fit within therecess 52 of each flange fitting 40 a, 40 b, 42 a, 42 b, 44 a, 44 b, 46a, 46 b, 48 a, 48 b, 50 a, 50 b. In this regard, a seal 70 can be placedinto the recess 52 so that a good fluidic seal can be formed betweenother devices and apparatus and the various complete flange fittings. Ofcourse, as stated herein, in certain embodiments, there is other typesof connectors or ends can be employed other than the specificallyillustrated flange fittings 40 a, 40 b, 42 a, 42 b, 44 a, 44 b, 46 a, 46b, 48 a, 48 b, 50 a, 50 b. These include plain tubes or ends configuredfor adapting to other types of connectors such as, for instance, theBioQuate Disposable Aseptic Connector (DAC) available from BioQuate,Inc., Clearwater, Fla., or the KLEENPAK sterile connector (Pall LifeSciences Products, East Hills, N.Y.).

The disposable conduit 8 may be made of un-reinforced silicone tubing.In this manner, there is no need to use expensive and inflexiblereinforced tubing. The first housing portion 4 and the second housingportion 6 serve to encapsulate the disposable conduit 8 in a sort ofexoskeleton that prevents the formation of aneurysms within thedisposable conduit 8. The encapsulated structure also enables very highpressure ratings for the encapsulated valve system 10. Whileun-reinforced silicone tubing may be used for the disposable conduit 8,other materials suitable for this purpose include by way of exampleC-FLEX tubing (Saint-Gobain, France) or tubing made of STA-PURE (W.L.Gore & Associates, Newark, Del.) or other types of thermoplasticelastomers (TPE), elastomeric, or silicone tubing, or other materialsknown to those skilled in the art. Generally, the un-reinforced tubingis made from a polymeric material.

FIGS. 5-7 illustrate an alternative embodiment of an encapsulated valvesystem 80. In this embodiment, the encapsulated valve system 80 includesa first housing portion 84, a second housing portion 86, and adisposable conduit 88 that, in an assembled state, is interposed betweenthe first housing portion 84 and the second housing portion 86. Theencapsulated valve system 80 further includes a plurality of pinch valveactuators 88, 90, 92. As seen in FIG. 5, pinch valve actuator 88 ismounted on the first housing portion 84 while pinch valve actuators 90,92 are mounted on the second housing portion 86.

The first housing portion 84 and the second housing portion 86 may besecured to one another using a fastener 94 that passes through aperture95. Of course other fasteners of the type described herein may also beused. The disposable conduit 88 may be formed from the same materialsdescribed above with respect to the embodiment of FIGS. 1-4. Thedisposable conduit 88 may include a seal or gasket 89 located atterminal ends thereof. The seal or gasket 89 may be integrally formedwith the conduit 88 or, alternatively, as a separate structure. Thus,the disposable conduit 88 may itself terminate in a seal or gasket 89.In addition, the first housing portion 84 and the second housing portion86 include flange fittings 96 a, 96 b, 98 a, 98 b, 100 a, 100 b, and 102a, 102 b that combine together (as halves) to form complete fittings asdescribed above. The pinch valve actuators 88, 90, 92 are illustrated asbeing pneumatically operated as described above. Of course, variousother types of pinch valve actuators may be employed.

FIG. 6 illustrates a cross-sectional view taken through the disposableconduit 88 that lies within the branch passageways 104. The first facingsurface 85 of the first housing portion 84 is illustrated. FIG. 7illustrates the corresponding second facing surface 87 of the secondhousing portion 86 that is brought into contact with (or near) the firstfacing surface 85 when the disposable conduit 88 is interposed betweentwo housing portions 84, 86. In this embodiment, a first pathway 106extends across the first facing surface 85 of the first housing portion84 and the second surface 87 of the second housing portion 86 (FIG. 7).A second pathway 108 extends across the first facing surface 85 of thefirst housing portion 84 and the second surface 87 of the second housingportion 86 (FIG. 7). A third pathway 110 is formed in both the firstfacing surface 85 and the second facing surface 87 and bridges the firstpathway 106 to the second pathway 108. As seen in FIG. 6, the thirdpathway 110 includes an aperture 112 that is dimensioned to receive apinching element from pinch valve actuator 88 which is the same aspreviously described herein.

FIG. 7 illustrates the underside of the second housing portion 86. Asseen herein, two apertures 114, 116 are formed in the first pathway 106and the second pathway 108. These apertures 114, 116 are dimensioned toreceive pinching elements from respective pinch valve actuators 90, 92which are the same as previously described herein. In thisconfiguration, the branch pathways 106, 108, 110 form an H-shape. Thedisposable conduit 88 is shaped in the form of an H as well with twoside portions 88 a, 88 b and a bridging portion 88 c. In thisconfiguration, the pinch valve actuator 88, when actuated, blocks flowbetween the first and second pathways 106, 108. The remaining pinchvalve actuators 90, 92 prevent fluid from passing into or exiting frompathways 106, 108. Again, this embodiment of the encapsulated valvesystem 80 may operate in a so-called block and bleed arrangement.

FIG. 8 illustrates an alternative embodiment of an encapsulated valvesystem 120. In this embodiment, the encapsulated valve system 120includes a first housing portion 122, a second housing portion 124, anda disposable conduit 126 that, in an assembled state, is interposedbetween the first housing portion 122 and the second housing portion124. The encapsulated valve system 120 further includes a plurality ofpinch valve actuators 128, 130, 132. As seen in FIG. 8, a pinch valveactuator 128 is mounted on the first housing portion 122 while pinchvalve actuators 130, 132 are mounted on the second housing portion 124.The various pinch valve actuators 128, 130, 132 operate in a similarmanner as described herein. Still referring to FIG. 8, a plurality ofbranch pathways includes first pathway 138, second pathway 140, andbridging pathway 142.

The first housing portion 122 and the second housing portion 124 may besecured to one another using a fastener 134 that passes through aperture136. Of course other fasteners of the type described herein may also beused. The disposable conduit 126 may be formed from the same materialsdescribed above with respect to the embodiment of FIGS. 1-7. In thisembodiment, the first housing portion 122 and the second housing portion124 do not include any flange fittings. Rather, the first and secondpathways 138 and 140 terminate simply at an opening (or exit as the casemay be) in the respective halves of the first housing portion 122 andthe second housing portion 124. In the embodiment of FIG. 8, theterminal ends 144 of the disposable conduit may optionally beconstructed to include fittings 146 that are designed to interface orconnect with other components. The particular fitting 146 may include asealing member, gasket, or the like that can then be used to create afluidic seal with another device or component. Of course, the particularfitting 146 may vary according to the particular application in whichthe encapsulated valve system 120 is used.

FIGS. 9-11 illustrate an encapsulated valve system 150 according toanother embodiment. The encapsulated valve system 150 includes a firsthousing portion 152, a second housing portion 154, and a disposableconduit 156 that, in an assembled state, is interposed between the firsthousing portion 152 and the second housing portion 154. The encapsulatedvalve system 150 further includes a plurality of pinch valve actuators160, 162, 164, 166, 168, 170, 172, 174. As seen in FIGS. 9-11, pinchvalve actuators 160, 162, 164, 166 are mounted on the second housingportion 154 while pinch valve actuator 168 is mounted on the firsthousing portion 152. The remaining pinch valve actuators 170, 172, 174are mounted along the interface or seam 176 created between the firsthousing portion 152 and the second housing portion 154. These pinchvalve actuators 170, 172, 174 are generally oriented perpendicular ororthogonal to the pinch valve actuators 160, 162, 164, 166, 168. Whileeight (8) pinch valve actuators are illustrated in FIGS. 9-11 more orless may be included depending on the particular configuration of theencapsulated valve system 150.

Referring to FIGS. 9 and 10, the first housing portion 152 has a firstfacing surface 178 that includes a plurality of branch passageways 180formed as a recess within the first facing surface 178 of the firsthousing portion 152. In particular, the recesses that form the pluralityof branch passageways 180 may be milled, worked, or molded into thefirst facing surface 178 as previously described herein. In a similarmanner, as best seen in FIG. 11, the second housing portion 154 has asecond facing surface 182 and includes a plurality of branch passageways184 formed as a recess within the second facing surface 182 of thesecond housing portion 154. The recesses formed in the second facingsurface 182 may be formed is the same manner with respect to thoserecesses within the first facing surface 178. In particular, the branchpassageways 180, 184 are formed the first and second facing surfaces178, 182, respectively, in a mirrored fashion such that thecorresponding recesses match to form a substantially concentricpassageway when the first facing surface 178 is brought into contact (orclose proximity) with the second facing surface 182.

Referring now to FIGS. 9-11, the plurality of branch passageways 180,184 terminate at respective flange fittings 186 a, 186 b, 188 a, 188 b,190 a, 190 b, 192 a, 192 b, 194 a, 194 b, 196 a, 196 b. Each flangefitting represents one-half of the complete flange fitting. Thus, whenthe first facing surface 178 and second facing surface 182 are broughttogether or in close proximity the complete flange fitting is formed.The complete flange fitting (e.g., 186 a and 186 b) appear circular inshape although other geometries may be utilized. The flange fittings 186a, 186 b, 188 a, 188 b, 190 a, 190 b, 192 a, 192 b, 194 a, 194 b, 196 a,196 b may be formed to conform to uniform standards within the relevantindustry or application. While it is contemplated that the flangefittings 186 a, 186 b, 188 a, 188 b, 190 a, 190 b, 192 a, 192 b, 194 a,194 b, 196 a, 196 b may be designed to conform to these standards orcommercial conventions other sizes are also contemplated to fall withinthe scope of the invention. Each flange fitting 186 a, 186 b, 188 a, 188b, 190 a, 190 b, 192 a, 192 b, 194 a, 194 b, 196 a, 196 b optionallyincludes a recess 198 (FIG. 9) that is dimensioned to receive seal orgasket similar to that discussed herein with respect to the embodimentof FIGS. 1-3.

Similarly, as an alternative to the flange fittings 186 a, 186 b, 188 a,188 b, 190 a, 190 b, 192 a, 192 b, 194 a, 194 b, 196 a, 196 b describedabove, the branch passageways 180, 184 may terminate in plain tubeendings or other types of connectors known to those skilled in the art.The connectors may be integrally formed into the first and secondhousing portions 152, 154 or they may be secured after formation of thefirst and second housing portions 152, 154. For example, the endings orconnectors may be welded, bonded, or otherwise affixed to the first andsecond housing portions 152, 154. The endings or connectors may beconfigured to adapt to other mechanical or heat-weldable union typesknown to those skilled in the art. Optionally, the first and secondhousing portions 152, 154 may not have any flange fittings, for example,as illustrated in FIG. 8.

Referring to FIG. 9, the first housing portion 152 and the secondhousing portion 154 may be secured to one another via a fastener 200.The fastener 200 is a screw or bolt that passes through apertures 202that are located in the first housing portion 152 and the second housingportion 154. The fastener 200 may include other devices such as clamps,bolts or the like. It may even be possible to use an adhesive bondbetween the first housing portion 152 and the second housing portion154. The fasteners 200 are configured to be removable such that thefirst housing portion 152 can be separated from the second housingportion 154 to remove the inner disposable conduit 156.

As best seen in FIGS. 10 and 11, along pre-selected portions of thebranch passageways 180, 184 there are provided apertures 206 that aredimensioned to receive a pinching element 208 (seen in FIG. 10) fromrespective pinch valve actuators 160, 162, 164, 166, 168, 170, 172, 174.The various apertures 206 are associated with a respective actuator asdescribed herein. The locations of the various apertures 206 are chosento provide the ability to valve or gate a fluid medium into one or moreselected branch passageways 180, 184 as previously described.

An advantage of having the pinch valve actuators 170, 172, 174 locatedalong the seam or interface 176 formed between the first housing portion152 and the second housing portion 154 is that this reduces the overallsize or footprint of the encapsulated valve system 150. This isparticularly important given that multiple encapsulated valve systems150 may be used in a particular process or operation. For example, asone alternative aspect, the actuator 168 may even be moved to a lateralposition along the seam 176. This would reduce the overall height of theencapsulated valve system. Another advantage of the embodiment of FIGS.9-11 is that the amount of residual volume of fluid contained in theencapsulated valve system 150 can be reduced.

FIG. 12 illustrates an embodiment similar to that illustrated in FIG. 5with the exception that the second housing portion 86 does not includeflange fittings 96 a, 96 b, 98 a, 98 b, 100 a, 100 b, and 102 a, 102 b.The embodiment illustrated in FIG. 12 also does not include a seal orgasket 89 located at the terminal ends of the disposable conduit 88.Instead, the terminal ends of the disposable conduit 88 merelyterminates at a cut end that then can be mating with any number ofconfigurations whether hygienic or non-hygienic known to those skilledin the art.

While FIG. 12 illustrates the pinch valve actuators 88, 90, 92 onopposing sides of the first and second housing portions 84, 86, itshould be understood that the pinch valve actuators 88, 90, 92 may belocated along a seam like that illustrated in FIGS. 9-11. The sameapplies to the embodiment of FIG. 5. While embodiments of the presentinvention have been shown and described, various modifications may bemade without departing from the scope of the present invention. Theinvention, therefore, should not be limited, except to the followingclaims, and their equivalents.

What is claimed is:
 1. A method of controlling flow for pressurizedpharmaceutical or biological liquid fluids comprising: inserting adisposable conduit comprising an un-reinforced polymer tubing having acommon line and a plurality of branch lines connected to the common linein a two-piece openable exoskeleton formed from a first housing defininga first flat facing surface and a second housing defining a second flatfacing surface, the first housing and the second housing each havingrespective pathways formed as recesses in the first flat facing surfaceand the second flat facing surface that form a substantially circularpassageway between the first and second flat facing surfaces, wherein atleast one automatically controlled pinch valve actuator is mounted onthe first housing and configured to pinch the disposable conduit alongthe common line and a plurality of automatically controlled pinch valveactuators are mounted on the second housing and configured to pinch thedisposable conduit along the plurality of branch lines; securing thefirst housing to the second housing in a closed state using one or morefasteners, wherein no portion of the disposable conduit between thefirst housing and the second housing is exposed to an externalenvironment and not encapsulated by the exoskeleton; flowing apressurized liquid in the disposable conduit; actuating one or more ofthe plurality of automatically controlled pinch valve actuators todivert flow from the common line to one or more of the branch lines;unsecuring the first housing from the second housing and replacing thedisposable conduit with a replacement disposable conduit and resecuringthe first housing to the second housing in the closed state; wherein thedisposable conduit is configured to carry the pressurized liquid fluidtherein that would otherwise form an aneurysm in the disposable conduitin the absence of the first housing and the second housing forming anexoskeleton for the same.
 2. The method of claim 1, wherein thedisposable conduit comprises silicone.
 3. The method of claim 1, whereinthe disposable conduit comprises seals disposed at terminal ends thereofand located outside the first housing and the second housing.
 4. Themethod of claim 1, wherein the one or more fasteners comprise at leastone of a screw, bolt, or clamp.
 5. The method of claim 1, wherein thefirst housing and the second housing comprises a polymer material. 6.The method of claim 1, wherein the first housing and the second housingcomprises a metallic material.
 7. The method of claim 1, wherein thefirst housing is unsecured from the second housing by loosening the oneor more fasteners and the first housing is resecured to the secondhousing by tightening the one or more fasteners.
 8. The method of claim1, further comprising connecting a terminal end of the disposableconduit to another component.
 9. The method of claim 8, wherein theterminal end of the disposable conduit comprising a fitting.
 10. Themethod of claim 1, wherein the disposable conduit comprises athermoplastic elastomer (TPE) tubing or elastomeric tubing.